Clinical trial sponsors are ultimately responsible for the integrity of the data generated by their vendors. Increased scrutiny by the FDA has only driven home this fact. When investigators ask how a sponsor oversees the activities and assures the quality of work performed by their clinical vendors, third-party quality oversight is the answer.

Quality oversight provides an unbiased and objective assessment of the vendor CRO work effort. It eliminates the inherent bias in a long-term relationship between a sponsor and its clinical trial CRO that makes it difficult for the sponsor to assess the CRO’s performance.

Quality oversight is not an additional quality product; it is not about co-monitoring or re-auditing; and it is not clinical quality assurance. It neither duplicates nor minimizes the importance of these functions. Rather, it is a directed response to pressure from the FDA to ensure the integrity of clinical data.

Why Beaufort?

Beaufort, LLC, is the first clinical research organization to offer quality oversight services. As a boutique firm that does not compete with larger contract research organizations for project work, Beaufort is uniquely positioned to provide quality oversight without threatening the vendor CRO. Our relationship is always collegial, not competitive.

Only the most experienced, uniquely qualified CRAs are selected as Beaufort quality oversight assessors. With a minimum of 10 years’ monitoring experience, each assessor must also have demonstrated oversight experience in roles such as lead CRA, CRA manager, SWAT member, clinical auditor, or trainer. Beaufort’s assessors bring GMP-quality methodology to the clinical process.

Quality Oversight Services

Beaufort’s basic quality oversight process observes, critically assesses and provides objective and unbiased feedback on an individual CRA’s level of knowledge, experience and training for specified trials.